EPSOLAY is an innovative topical encapsulated benzoyl peroxide cream with a 5% concentration for the treatment of papulopustular rosacea.
Benzoyl peroxide is known to be an effective treatment for rosacea, but causes significant irritation. Our silica-based microencapsulation delivery system creates a silica barrier between benzoyl peroxide crystals and the skin, and as a result is expected to reduce irritation typically associated with topical application of benzoyl peroxide, thereby making the drug tolerable to rosacea-affected skin. Our solution also alters the release profile of the drug substance to reduce skin irritation while maintaining efficacy. In a double-blind, randomized, dose-ranging Phase II clinical trial for EPSOLAY, involving 92 adult patients at ten centers in the U.S., EPSOLAY demonstrated statistically significant efficacy versus the control vehicle.
Moreover, the safety and tolerability profile of EPSOLAY was similar to that of the vehicle. In the first half of 2018, we expect to commence two double-blind, placebo controlled, multi-center pivotal Phase III clinical trials for EPSOLAY in the U.S, with results within one year after commencement. Click here for phase 2 data on EPSOLAY
TWIN is a novel non-antibiotic cream for the treatment of acne vulgaris (acne) that was designed to be tolerable and highly effective. It is the first acne treatment that contains a fixed-dose combination of encapsulated tretinoin and encapsulated benzoyl peroxide.
While major challenges were the instability of tretinoin in the presence of benzoyl peroxide and irritation, encapsulation allows stabilization and is also expected to contribute to patient compliance.
The silica microcapsule protects tretinoin from oxidative decomposition by benzoyl peroxide, thereby enhancing the stability and clinical and commercial shelf-life. The silica shell also creates a barrier between the drug substances and the skin and as a result is expected to reduce irritation typically associated with topical application of benzoyl peroxide and tretinoin, thereby increasing the tolerability of TWIN on acne-affected skin.
Pre-clinical data demonstrates that TWIN exhibits increased tolerability relative to non-encapsulated tretinoin and when compared to Epiduo, without any corresponding loss in efficacy. We believe that TWIN is more effective than Epiduo because it contains tretinoin as opposed to adapalene, and tretinoin is known to be more effective than adapalene as a standalone acne treatment, but generally causes greater skin irritation.
During 2017, we have completed a double-blind, dose-ranging placebo-controlled, six-arm, multicenter Phase II trial in the U.S. Click here for TWIN phase II results.
Opportunity exists for shift from prescribing tretinoin and existing combinations to prescribing TWIN
SIRS-T, a topical encapsulated tretinoin cream, is being developed for dermatologists and patients that have a preference for using an efficacious and more tolerable tretinoin. SIRS-T’s efficacy and safety have been evaluated in TWIN phase II trial.
The silica shell creates a barrier between the drug substances and the skin and as a result is expected to reduce irritation typically associated with topical application of tretinoin, making SIRS-T more tolerable to acne-affected skin. The release profile of tretinoin was tuned to reduce irritation while maintaining efficacy. We believe that a more tolerable tretinoin drug product will improve patients’ compliance.
In a cumulative 14-day non-occlusive skin irritation trial with 14-day recovery in five Göttingen minipigs, we compared SIRS-T to generic tretinoin gel 0.1%. Erythema and edema were scored as very slight, well-defined, moderate or severe, and were monitored over the 28 day period. SIRS-T 0.1% was found to be non-irritant, similar to the untreated group, while generic tretinoin gel 0.1% was shown to be irritating.
Subject to an End of Phase II meeting to be scheduled with the FDA with regard to the Phase II TWIN trial, we plan to commence a pivotal Phase III program for SIRS-T in the United States in 2020 and expect to report top-line data from this program in 2021.
Six collaborations with Perrigo and one with Douglas Pharmaceuticals with 50/50 gross profit sharing.
In February 2019, Perrigo received approval from the FDA for acyclovir cream, 5%, developed in collaboration with Sol-Gel.
In January 2018, Perrigo received tentative approval from the FDA for ivermectin cream, 1%, developed in collaboration with Sol-Gel. Perrigo was second to file and, as of today, there is no public disclosure of another tentative approval or a third filer to the FDA.
Bioequivalence study results for 5-fluorouracil cream, 5%, in 2019.
In addition to advancing our lead product candidates, we are also engaged in the formulation and pre-clinical development of early stage innovative product candidates for both current focus indications, such as acne and rosacea and for other dermatological indications.
Four of our generic drug product candidates are being developed in collaboration with Perrigo and one with Douglas Pharmaceuticals.
We plan to initiate a bioequivalence study regarding another generic drug candidate in H2/2018.